Clinical trial · Interventional
DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
Phase II Open-Label Study of Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer
NCT00024414CI-TRIAL-00001605unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DHA-paclitaxel | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Progressive metastatic disease on continuous hormonal therapy (e.g., orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist)
* Progressive disease is defined by all of the following:
* Measurable disease or lesions on bone scan
* Increases in prostate-specific antigen (PSA) levels on at least 2 consecutive measurements
* Continued PSA elevation after cessation of prior antiandrogen therapy (4 weeks after flutamide and nilutamide and 8 weeks after bicalutamide)
* PSA level at least 5 ng/mL
* Serum testosterone level less than 50 ng/mL
* Patients who have not undergone prior surgical castration should continue primary androgen suppression (LHRH agonist)
* No known or clinical evidence of CNS metastasis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No uncontrolled ventricular arrhythmia
* No myocardial infarction within the past 3 months
* No superior vena cava syndrome
Neurologic:
* No peripheral neuropathy greater than grade 1
* No uncontrolled major seizure disorder
* No spinal cord compression
Other:
* No psychiatric disorder that would preclude informed consent
* No unstable or serious concurrent medical condition
* No concurrent serious infection requiring parenteral therapy
* No other prior or concurrent malignancy except:
* Curatively treated nonmelanoma skin cancer OR
* Other cancer curatively treated with surgery alone that has not recurred for more than 5 years
* Fertile patients must use effective contraception during and for at least 6 months after study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior taxanes
* Prior mitoxantrone or prednisone for metastatic disease allowed
* At least 28 days since prior chemotherapy and recovered
* No other concurrent chemotherapy
Endocrine therapy:
* See Disease Characteristics
* No concurrent hormonal therapy
Radiotherapy:
* No prior samarium SM 153 lexidronam pentasodium or strontium chloride Sr 89
* Prior external radiotherapy for metastatic disease allowed
* At least 28 days since prior large-field radiotherapy and recovered
* No concurrent radiotherapy, including whole-brain radiotherapy for documented CNS metastasis
Surgery:
* See Disease Characteristics
* At least 14 days since prior major surgery and recovered
Other:
* No other prior nonhormonal treatment for metastatic disease
* At least 28 days since prior herbal preparations (e.g., PC-SPES) and recovered
* No other concurrent anticancer medicationsReferences
Publications (0)
Data not yet available
No reference posted for this study.